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Effect of dopamine on renal function in diabetic patients undergoing coronary artery bypass surgery by extracorporeal circulation

Protocol summary

Summary
Objectives: The aim of this study was to evaluate the effect of renal dose dopamine on renal function in diabetic patients undergoing coronary artery bypass surgery.Research Design: Conduction of a randomized, double-blind, clinical trial.Inclusion criteria: CABG surgery patients with heart bypass, diabetic patients, and patients with EF more than 30%Patients with BUN lower than 30 mg / dl, Patients with serum creatinine less than 5 mg / dl1.5Exclusion criteria: Age over 70 years, The combined surgical procedure, reoperation, The use of balloon pump, hyper-thyroidism, patients with contraindications for use dopamine such as pheochromocytoma, dialysis for history of Renal Failure, patients with serum creatinine equal to or more than 1.5 dl / mg, patients with EF equal and less than 30%, patients with BUN more than 30 dl / mg, patients with kidney and liver problems, patients who we had to use a higher dose of 0.05 isotropic in the operating room and ICU, The left ventricular dysfunction.To determine the effect of renal dose dopamine in diabetic patients undergoing coronary artery bypass surgery at 7am in the first, second and third days after surgery and 1 hours after surgery CR,BUN,K ,Cr CLEARANCE will be measured . Interventions: In this randomized study, 86 patients with normal renal function will randomly assign into two groups. Group dopamine receives infusion of 3 µg / kg / min dopamine to 24 hours after the induction of the anesthesia but the control group does not receive medical treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015110823716N1
Registration date: 2015-12-29, 1394/10/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-12-29, 1394/10/08
Registrant information
Name
Homeira Moradi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3833 0561
Email address
stud2300955679@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Science
Expected recruitment start date
2016-02-01, 1394/11/12
Expected recruitment end date
2016-06-30, 1395/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dopamine on renal function in diabetic patients undergoing coronary artery bypass surgery by extracorporeal circulation
Public title
Effect of dopamine on renal function in diabetic patients undergoing cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: CABG surgery patients with heart bypass; diabetic patients; patients with EF more than 30% Patients with BUN lower than 30 mg / dl; Patients with serum creatinine less than 5 mg / dl1.5 Exclusion criteria: Age over 70 years; The combined surgical procedure; reoperation; The use of balloon pump; hyper-thyroidism; patients with contraindications for use dopamine such as pheochromocytoma; dialysis for history of Renal Failure; patients with serum creatinine equal to or more than 1.5 dl / mg; patients with EF equal and less than 30%, patients with BUN more than 30 dl / mg; patients with kidney and liver problems; patients who we had to use a higher dose of 0.05 isotropic in the operating room and ICU; The left ventricular dysfunction
Age
To 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SUMS.REC.1394.59

Health conditions studied

1

Description of health condition studied
Diabets type I,II
ICD-10 code
(E10-E14)
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
renal function
Timepoint
At 7am in the first ,second and third days after surgery and 1 hours after surgery
Method of measurement
CR,BUN,K ,Cr CLEARANCE

2

Description
clearance Cr
Timepoint
At 7am in the first ,second and third days after surgery and 1 hours after surgery
Method of measurement
: (140-age)× wt / 72× Pcr (in female × 0.85) = Cockroft

Secondary outcomes

1

Description
Check intake and output
Timepoint
during 8 pm to 8 am after operation and 24 hrs after 8 am
Method of measurement
by ICU sheet

Intervention groups

1

Description
Group intervention received infusion of 3 µg / kg / min dopamine to 24 hours after the induction of the anesthesia
Category
Treatment - Drugs

2

Description
The control group did not receive medical treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
MRI and Ordibehesht Hospital
Full name of responsible person
Homeira Moradi
Street address
Chamran Blv
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sc
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research ,Shiraz University of Medical Sciences-7th floor-Central Building of Shiraz University of Medical Sciences , Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical Sc
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Homeira Moradi
Position
Anesthesia Nurse
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
homaira.m90@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Mohammad Hasan Nemati
Position
Cardiosurgeon
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 9871364774270
Fax
Email
nemati_mhs@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching
Other areas of specialty/work
Street address
Fifth Floor, Mohammad Rasoulallah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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